At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 23 enrolled
Drug / intervention
BGF +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Two Treatment, Two Period, Chronic Dosing (4 Weeks), Crossover, Multi-center Pilot Study to Evaluate the Effects of Budesonide/Glycopyrronium/Formoterol Fumarate and Glycopyrronium/Formoterol Fumarate on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
In Brief
A Phase 3 clinical trial evaluating BGF and GFF for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 23 participants across 4 sites in 2 countries.
Detailed Summary
This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and Glycopyrronium/Formoterol Fumarate (GFF) on airway dimensions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Netherlands
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartFeb 2019
Primary CompletionNov 2019
TodayJul 2026
First PostedFeb 11, 2019
Enrollment StartFeb 26, 2019
Primary CompletionNov 11, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.4 years ago
Interventions
BGFcombination
Treatment with Budesonide/Glycopyrronium/FormoterolFumarate
GFFcombination
Treatment with Glycopyrronium/Formoterol Fumarate